Chromic Gut GG-181Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884521055018), received between Jan 22, 2019 and Jun 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

3 other recalls cover devices cleared under the same FDA submission (K142656, K885018); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 5, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING AN OPEN VETERINARY DENTAL CLOSURE OF THE GUMS, SUTURE THREAD HAD BROKE WHEN BEING TIED. A COMPETITOR SUTURE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17065888 ↗
• MalfunctionJan 18, 2021Break; Unraveled Material; Material Twisted/Bent; Break; Unraveled Material; Material Twisted/Bent

  ACCORDING TO THE REPORTER, DURING TOOTH EXTRACTION ON A VETERINARY PROCEDURE, WHILE USING SIMPLE INTERRUPTED TECHNIQUE, THE NEEDLE BENT, AND SUTURE WAS BREAKING. A WEEK LATER, THE PATIENT CAME BACK. THE TOOTH CAME OUT AND THE FLAP WAS OPEN, THE SURGEON RE-SUTURED AGAIN TO RESOLVE THE ISSUE. PATIENT HOSPITALIZATION WAS EXTENDED AS A RESULT OF THE EVENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 11187863 ↗
• MalfunctionJan 22, 2019Break; Break

  ACCORDING TO THE REPORTER, ON A CIRCUMCISION, A MINUTE INTO THE PROCEDURE, WHILE CLOSING THE WOUND USING A CONTINUOUS SUTURING TECHNIQUE, THE THREAD OF THE SUTURE BROKE. IT WAS STATED THAT THE ABSORBABLE SUTURE BEEN OPENED OR REMOVED FROM THE PACKAGING FOR 5 MINUTES PRIOR TO USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8267320 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K142656, K885018. One submission often covers many models, so check the product and lot details in each record.

• Z-1390-2023 · Mar 1, 2023 · Open, Classified
  Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
• Z-1389-2023 · Mar 1, 2023 · Open, Classified
  Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
• Z-1388-2023 · Mar 1, 2023 · Open, Classified
  Chromic Gut Absorbable Sutures, SURGIGUT* 0 CHR GS-25 90CM X36 (CG-904), SURGIGUT* 1 CHR GS-24 90CM X36 (CG-915), CHROMIC GUT 4-0 75CM V20 (GG-121), CHROMIC GUT 3-0 75CM V20 X36 (G